www.hhcresearch .com info@hhcresearch.com

Healing Hands Clinical Research Services is a Site Management organization with broad spectrum of activities including Site Selection, Site Feasibility, site management, Project Management, Monitoring, clinical operations and safety management supporting early-phase through late-phase clinical development programs.

We have extensive working knowledge of a wide range of products such as Pharmaceutical/ biotechnology products, biologics and herbal products and all activities are carried out in strict compliance with ICH GCP, schedule Y, ICMR and all applicable guidelines.

What We Are

Cont…

Our comprehensive investigator database and expertise in various therapeutic areas like General Surgery, Medicine, Diabetology, Oncology, Cardiology, Nephrology, Immunology, Rheumatology, Infectious diseases, Gynecology, orthopedics and Gastroenterology..etc give us significant leverage in providing faster patient recruitment, cost competitive trials, yet world-class clinical support.

Our Team:•Highly experienced and receptive team

•5 to 10 years experience in the Pharmaceutical industry

•Well trained and potential staff (ICH-GCP, ICMR, Schedule-Y and FDA

regulations)

•Experience with all phases of clinical trials (Phase II -IV) across multiple

therapeutic areas, in both paper and EDC environments

•Immaculate track record for delivery on time and with quality

Our Strengths•Manage Global as well as domestic clinical trials with precision and perfection.

•Having Comprehensive project management team, quality expert management

team and potential site coordinators

•Timely execution of sponsors/CRO requirements

•Potential Investigators and sites

•Faster Patient Recruitment

•Maintaining quality of the data

•Resolving and responding to all the queries within timelines

•Strict compliance with study timelines and protocol

•Work with a variety of sponsor’s compounds

•Effective communication

•Compliance with FDA, local regulatory and ICH-GCP guidelines.

Our Services:

We offer a broad range of specialized services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to the market faster.

We offer:1. Site Selection and Site Feasibility 2. Project Management 3. Site Initiation to Close out Services 4. Monitoring 5. Safety management

We have a good experience in the complete process - site evaluation, site initiation, site management and finally site closeout – so we can ensure prompt response at every stage of the study.

We Involve in: A) Pre Study initiation

Identification of Potential Sites

Faster Feasibility completion

Site set up, supplies and other infrastructure needs

Regulatory and IEC communications

Rapid negotiation of CTA with CRO/Sponsors and investigators

Setting up Standard Operating Procedures (SOPs) for site

B) During the Study/Trial’s

Provide dedicated, trained and experienced CRCs (Clinical research coordinators)

Patient recruitment & retention Support

Maintenance of essential documents

Maintenance of TMF (Trial Master Files)

Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate)

IP(Investigational Product) storage, maintenance and accountability

Completion of CRF’s within timelines Cont…..

Faster query resolution

Reporting of AE, SAEs to the sponsor and Ethics committee within timelines

Timely submission of CIOMS to the IRB/IEC

Support Monitoring visits and Quality Assurance audit action items

Patient visit Follow Up and compliance assistance

Preparation of site for monitoring and audits/ inspections

Project management and quality management by quality experts.

C) Pre Close out and Post Close out

Preparation for site Close out visit

Archiving of site results and documents

Preparation and maintenance of quality in case of management of clinical trials data and medications at hospital or institute level is one of the best service provided by us.

Therapeutic areas:Healing Hands Clinical Research services deals with all major Therapeutic areas with India’s leading and potential Investigators. We expertise in following therapeutic areas:

1.Medicines 2.Hematology3.Endocrinology4.Infectious Disease5.Gastroenterology6.General Surgery

7. Oncology 8. Cardiology 9. Neurology10. Nephrology11. Psychiatry12. Orthopedic13. ENT14. Obstetrics & Gynecology15. Pediatric 16. Herbal Research17. Neutraceuticals

Our Specialties: We offer quality services for investigators, enabling them to organize, perform and execute successful clinical trials. We are mostly affiliated with Multi-specialty Hospitals across India.

As a Site Management Organization, we assist Clinical Investigators and Hospitals who have excellent sites to qualify for new clinical trials.

Our Project management and quality expert’s team will assure the quality of the data. We work closely with Sponsor/ CRO’s as a team and provide end to end site management solutions.

Why choose HHCRS: •Full range of clinical SMO services

•Quality driven work

•We manage, plan, and execute clinical trials with precision and perfection

• We are a dedicated, meticulous group of professionals who consistently produce quality work.

•Having High recruitment sites across India.

•Accelerating work strategies right from feasibility, site selection to site close out.

•Dedicated and potential coordinators working at the sites.

•Compliance with the protocol and applicable regulatory guidelines..

Healing Hands Clinical Research Services 4th Floor, Millennium star Extension,

Above KFC, Adjacent to Ruby Hall Entrance Gate, Dholepatil Road, Pune-01.

www.hhcresearch.com info@hhcresearch.com